Amwell CFO sells over 222,000 class A common shares » 16:3501/2201/22/21
In a regulatory filing,…
In a regulatory filing, American Well CFO Keith Anderson disclosed the sale of 222,054 class A common shares of the company on January 20 at a price of $26.4275 per share.
Quidel upgraded to Outperform from Market Perform at Raymond James » 09:1901/2201/22/21
Raymond James analyst…
Raymond James analyst Andrew Cooper upgraded Quidel to Outperform from Market Perform with a $250 price target. Cooper believes Quidel's core business is well positioned to exit the pandemic much stronger than it entered. The analyst thinks the stock can work even amidst an eventual top-line decline on waning COVID-19 testing.
Amarin remains undervalued under almost any scenario, says Cowen » 07:5101/2201/22/21
Cowen analyst Ken…
Cowen analyst Ken Cacciatore believes Amarin shares remain undervalued remain undervalued under almost any scenario and said its valuation appears too discounted. He believes the company's best path forward it to cease US promotional spending to maximize profitability and then sell the company for European value, Cacciatore maintained his Outperform rating and $10 price target on Amarin shares.
BioCryst announces approval of ORLADEYO in Japan » 07:0701/2201/22/21
BioCryst Pharmaceuticals announced that the Ministry of Health, Labor and Welfare in Japan has granted marketing and manufacturing approval for oral, once-daily ORLADEYO 150 mg for prophylactic treatment of hereditary angioedema in adults and pediatric patients 12 years and older. ORLADEYO is the first and only prophylactic HAE medication approved in Japan. One capsule of ORLADEYO per day works to prevent HAE attacks by decreasing the activity of plasma kallikrein. ORLADEYO will be commercialized in Japan by BioCryst's partner, Torii Pharmaceutical Co., Ltd. OrphanPacific, Inc. is BioCryst's representative partner in Japan and holds the marketing authorization. Torii will launch ORLADEYO in Japan following the successful completion of BioCryst's pricing negotiations with the Japanese National Health Insurance System. In December 2020, the U.S. Food & Drug Administration approved ORLADEYO in the U.S. In Europe, the European Medicines Agency validated its marketing authorization application submission for ORLADEYO and formal review of the MAA under the centralized procedure is underway. The company expects an approval decision in Europe in the second quarter of 2021. With the approval in Japan, BioCryst is eligible to receive an additional milestone payment of $15M from Torii upon receipt of a reimbursement price approval from Japan's National Health Insurance system in excess of the threshold specified in the agreement with Torii. In addition, BioCryst will receive tiered royalties ranging from 20 percent to potentially 40 percent of Japanese net sales.
Quidel upgraded to Outperform from Market Perform at Raymond James » 04:4701/2201/22/21
Raymond James analyst…
Raymond James analyst Andrew Cooper upgraded Quidel to Outperform from Market Perform with a $250 price target.
Fly Intel: After-Hours Movers » 18:3501/2101/21/21
SIVB, WAL, INDB, OZK, FLDM, MNOV, SWIR, ALDX, AMRN, IBM, STX, PPG, ISRG, CSX, PGEN, ACB, F
Check out this evening's…
Amarin announces CSC included icosapent ethyl in CD prevention guidelines » 18:2701/2101/21/21
The company states:…
The company states: "Amarin announced that the Chinese Society of Cardiology, or CSC, has included icosapent ethyl in its updated Guidelines for Primary Prevention of Cardiovascular Diseases for 2021 as published in the Chinese Journal of Cardiovascular Diseases. The guideline authors include "icosapent ethyl grams twice a day as a treatment consideration to further lower atherosclerotic cardiovascular disease (ASCVD) in the appropriate patient population. In November 2020, Amarin shared positive, statistically significant top-line results from a Phase 3 clinical trial of VASCEPA conducted in China by Amarin's partner, Edding. The study, which investigated VASCEPA as a treatment for patients with very high triglycerides (greater than or equal to500 mg/dL), met its primary efficacy endpoint and demonstrated a safety profile similar to placebo. This pivotal study mirrored Amarin's MARINE study in patients from the United States and other countries and showed consistency across the Chinese and non-Chinese study populations. These findings will provide support as Edding progresses towards and through the next steps of regulatory submission and review of VASCEPA for potential approval in Mainland China. The CSC recommendation is classified as a Category IIa recommendation denoting that icosapent ethyl is useful and effective and should be considered for treatment of at-risk patients. The classification is an Evidence Level B recommendation which reflects that the evidence comes from a single randomized trial or multiple large non-randomized studies. CSC cited that its recommendations are supported by the results of the REDUCE-IT cardiovascular outcomes study. The CSC does not provide endorsements of any brand name commercial product. Accordingly, CSC Guidelines for Primary Prevention of Cardiovascular Diseases reference icosapent ethyl. The CSC guideline does not reference VASCEPA, the brand name of icosapent ethyl in the United States, and such guideline should not be construed as an endorsement or approval by the CSC of VASCEPA."
Illumina wins patent infringement suit against BGI in U.K. » 16:0601/2001/20/21
The company states:…
The company states: "Illumina announced that the High Court of Justice, Chancery Division, Patents Court, issued a judgment in its favor in the patent infringement suit filed against the BGI Companies, MGI Tech Co. Ltd; Latvia MGI SIA; MGI International Sales Co., Ltd; and BGI Complete Genomics Hong Kong Co., Ltd. Courts in the US, Germany, Spain, Finland and Sweden have issued injunctions against BGI. The Court had previously issued a preliminary injunction against BGI's UK-based sequencing laboratory and restricted BGI's ability to supply the infringing sequencing systems in the UK. Illumina intends to seek a permanent injunction fully prohibiting the supply or sale of BGI's StandardMPS and CoolMPS systems in the UK until the relevant patents expire. Additional lawsuits are pending in Hong Kong S.A.R., France, Belgium, Denmark, Switzerland, Turkey and Italy."
1Life Healthcare jumps after William Blair sees vaccine rollout benefits » 09:4501/2001/20/21
William Blair analyst…
William Blair analyst Ryan Daniels sees 1Life Healthcare as a potential derivative beneficiary from the administration of Covid-19 vaccines. The company's support for vaccines in New York, Seattle and the San Francisco area, coupled with its plans to provide complimentary services to qualifying patients, could increase sales from vaccinations and "serve as a bit of a Trojan-horse marketing campaign to acquire new members," Daniels told investors earlier in a research note. The analyst keeps an Outperform rating on the shares. 1Life Healthcare in early trading is 9%, or $4.51, to $52.22.
ShockWave Medical downgraded to Neutral from Overweight at Piper Sandler » 05:0001/2001/20/21
Piper Sandler analyst…
Piper Sandler analyst Adam Maeder downgraded ShockWave Medical to Neutral from Overweight with a price target of $132, up from $96. The analyst steps to the sidelines "for the time being due to valuation." Additionally, he believes the resurgence of COVID-19 cases and "fairly high" buy-side expectations make for a "less-than-optimal" setup heading into the Q4 results. Maeder thinks the stock already reflects some upside to numbers and is unsure how much more multiple expansion will materialize over the next 12 months.